PTN Studies

The PTN conducts Phase 1-4 trials and data-based studies across a broad range of conditions affecting pediatric patients.

ONGOING STUDIES

Study Name Status Population Condition Study Type ClinicalTrials.gov ID
Antibiotic safety (SCAMP) Enrolling Premature infants Intra-abdominal infections Interventional NCT01994993
Anti-epileptic obesity Enrolling Obese children Epilepsy Interventional NCT02993861
Baby TAPE Analysis ongoing Newborns and young infants NA (Weight estimation tool) Interventional
Baby TAPE III Enrolling Newborns and young infants NA (Weight estimation tool) Interventional
Caffeine Analysis ongoing Premature infants and infants Bronchopulmonary dysplasia Retrospective data collection
Furosemide Enrolling Premature infants Bronchopulmonary dysplasia Interventional  NCT02527798
Long-term Antipsychotic Pediatric Safety Trial (LAPS) Start-up Children Mono-antipsychotic therapies Observational
Midazolam Analysis ongoing Children (≥2 y) Seizures Retrospective data analysis NA
Personal protective equipment (PPE) Enrollment closed Research doctors and nurses Evaluating impact of various PPE Interventional NA
POPS Enrolling Children (<21 y) Various (drugs administered regularly by physicians) Observational  NCT01431326
Sildenafil II Enrolling Premature infants Bronchopulmonary dysplasia Phase 2 NCT03142568
Timolol Enrolling Infants Infantile hemangioma Phase 2  NCT02913612
Trimethoprim-sulfamethoxazole and clindamycin Analysis ongoing Children Skin and soft tissue infections Data from 3 protocols NCT01431326, NCT01728363, NCT01744730

COMPLETED STUDIES

Study Name Status Population Condition Study Type ClinicalTrials.gov ID
Acyclovir Closed; clinical study report submitted to FDA Premature infants Systemic infection Phase 1 NCT00942084
Acyclovir retrospective Closed; clinical study report submitted to FDA Infants Herpes simplex virus Retrospective data collection
Ampicillin Published; clinical study report submitted to FDA Infants Bacterial infections including sepsis and meningitis Secondary data analysis
Anti-staph trio Completed Premature infants Staphylococcal infections Interventional  NCT01728363
Clindamycin obesity Clinical study report submitted to FDA Obese children Staphylococcal infections Phase 1 NCT01744730
Diuretic safety Clinical study report submitted to FDA Infants Bronchopulmonary dysplasia Retrospective observational  NA
Fluconazole safety Published; clinical study report submitted to FDA Infants Candidemia Meta-analysis NCT00734539
Hydroxyurea Clinical study report submitted to FDA Children (2-4 y) Sickle cell anemia or sickle beta-zero thalassemia Phase 2 NCT01506544
Lisinopril PK Completed; label changed Children and adolescents (2-17 y) Kidney transplant; high blood pressure Interventional NCT01491919
Lorazepam Completed; label changed Children and adolescents (3 mo-18 y) Status epilepticus (Status 1) Interventional NCT00114569
Lorazepam or diazepam Clinical study report submitted to FDA Children and adolescents (3 mo-18 y) Pediatric status epilepticus (Status 2) Interventional NCT00621478
Meropenem Completed; label changed Infants Intra-abdominal infections Interventional NCT00621192
Methadone Completed Children Opiate withdrawal Observational NCT01945736
Metronidazole Published; clinical study report submitted to FDA Premature infants Serious infection caused by anaerobic bacteria Interventional NCT01222585
Obesity informatics Published Children Various Systematic literature review  NA
Pantoprazole Completed Obese children GERD Phase 1 NCT02186652
Pediatrix meta-analysis Published; clinical study report submitted to FDA Infants Various Meta-analysis  NA
Sildenafil Completed Premature infants Bronchopulmonary dysplasia Phase 1 NCT01670136
TAPE Published; clinical study report submitted to FDA Children (2-16 y) NA (Mercy Method™ for weight estimation) Observational NCT01507090